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NCT Number: NCT03845205

Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH

Given the severe consequences of alcohol relapse following liver transplantation for alcoholic hepatitis (AH-LT), it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize patient outcomes. The proposed randomized clinical trial will examine the implementation and effects of integrated, person- and computer-delivered alcohol treatment compared to standard care on alcohol use (assessed by self-report and biomarker), mood, quality of life and survival following AH-LT. Predictors of 12-month post-transplant alcohol outcomes will be explored to allow future improved tailoring and targeting of these treatments.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Mary E McCaul, Ph.D.

CONTACT

[email protected]

410-955-9526

About this study

In the United States, alcoholic liver disease (ALD) is the second most common indication for liver transplant (LT). Traditionally, ALD patients have been required to complete a six-month mandatory period of alcohol abstinence before LT. More recently early LT for severe alcoholic hepatitis is being performed without any pre-transplant alcohol treatment because of the high medical acuity and mortality associated with this disease. Importantly, the limited studies to-date demonstrate comparable survival among early (ELT) versus standard (SLT) transplant recipients. Return to alcohol use is a major concern for all LT recipients with ALD, with estimates of alcohol relapse ranging between 16 and 49%. Although most LT clinics have enforced pre-LT alcohol treatment, far less attention has been paid to post-LT services, despite the high risk and severe consequences of relapse during this period. Numerous evidence-based treatments are available for alcohol use disorder (AUD). In recent years, the investigators and others have developed web- and text-based versions of these empirically-supported interventions to expand the reach and replicability outside of formal alcohol clinic settings. Delivery of AUD interventions in non-traditional settings is feasible, acceptable to patients, and effective in reducing alcohol use. The investigators propose to implement and evaluate the effects of alcohol treatment integrated into routine post-LT care. All patients receive physician instructions to stop drinking and engage in alcohol services (treatment as usual: TAU). ELT (N=100) and SLT (N=100) patients will be randomized on a 2:1 basis to integrated AUD treatment (IAT) or TAU. IAT will include computer-delivered BI in the hospital, nurse-delivered alcohol monitoring counseling at each outpatient LT follow-up visit, and at-home participation in web-based, 7-session CBT4CBT, supplemented by tailored text messages. Also, because of the evidence that ALD patients significantly underreport drinking to LT providers, the investigators will compare post-LT alcohol relapse rates using a well-validated biomarker of recent drinking (PEth), patient self-report on a validated alcohol instrument, and patient report to LT provider. Finally, the investigators will identify predictors of post-LT alcohol use and treatment engagement for ELT and SLT patients. Key measures will include: alcohol use; engagement in alcohol treatment; retention in post-transplant follow-up care; mood and anxiety; and quality of life. Given the severe consequences of alcohol relapse among both ELT and SLT recipients, it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize short- and long-term patient outcomes and ultimately tailor treatments for this high-risk population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking

Exclusion criteria

  • too medically/psychiatrically ill to participate
  • not able to provide informed consent due to cognitive impairment

Treatment and study plan

Integrated AUD Treatment

Behavioral

IAT will include computer-delivered BI in the hospital, nurse-delivered alcohol monitoring counseling at each outpatient LT follow-up visit, and at-home participation in web-based, 7-session CBT4CBT, supplemented by tailored text messages.

Other names: Computerized brief alcohol intervention (CBI), CBT4CBT, Text Messaging

Primary outcomes

  1. Treatment engagement as assessed by proportion of kept LT follow-up appointments

    Time frame: 1 year

    Proportion of kept/scheduled LT follow-up appointments

  2. Alcohol relapse as assessed by time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL

    Time frame: 1 year

    Time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL (minimum detectable level)

  3. Post-liver transplant survival as assessed by time to death

    Time frame: 1 year

    Time to death (in months)

Secondary outcomes

  1. Alcohol relapse as assessed by Timeline Followback Interview

    Time frame: 1 year

    Any alcohol use reported on the Timeline Followback Interview

Study contacts

Contact information is provided by the study sponsor or research team.

MARY E MCCAUL, PhD

CONTACT

[email protected]

410-955-9526

Victor Chen, MD

CONTACT

[email protected]

410-550-1793

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for Severe Alcoholic Hepatitis (SAH)

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2019
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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